SAN DIEGO—Last month, Seattle Genetics scored an ultrafast FDA nod for Adcetris in patients with newly diagnosed peripheral T-cell lymphoma, and data presented at the American Society of Hematology annual meeting show why.
Late Monday, the biotech rolled out data showing that adding Adcetris to a cocktail of cyclophosphamide, doxorubicin and prednisone (CHP) could top a standard-of-care regimen known as CHOP—which combines CHP and vincristine—not only at keeping disease at bay, as the company had previously disclosed, but also at prolonging patients' lives, too. The Adcetris combo posted a 34% reduction in the risk of death as part of a phase 3 study dubbed Echelon-2.
The expanded data follow Seattle Genetics’ October top-line announcement that Adcetris had reduced the risk of disease progression or death by 29%. Patients in the study’s Adcetris arm lived a median 48.2 months without their cancer worsening, compared with 20.8 months for patients in the CHOP arm, regulators said at the time.
“We more than doubled the median progression-free survival of the standard of care that’s existed for 35 years, and to me, you don’t see that every day,” CEO Clay Siegall, Ph.D., said in an interview over the weekend.
The new ASH results also include secondary endpoint wins for Adcetris. The drug mustered an overall response rate of 83% versus CHOP’s 72%, as well as a complete response rate of 68% compared with the 56% that CHOP put up.
With an FDA approval already in hand, courtesy of the agency's new Real Time Oncology Review pilot program, Seattle Genetics has already begun to roll out Adcetris in its new patient population. The company is fielding a commercial team of about 135 people, 90 of whom are on-the-ground reps, Siegall said.
While the company hasn’t given sales guidance around the launch—it expects to do that on its next quarterly conference call in February—“what I can tell you is we hit the ground running,” Siegall said. The company got a head start on its rep training, meaning it wasn’t blindsided by the FDA’s early OK.
“We wanted to be launch-ready extremely early, and we made that decision a long time ago,” Siegall said, adding, “in hindsight, I’m really glad we” did.